(261 days)
Not Found
Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
Yes
The "Intended Use / Indications for Use" section explicitly states that the SilentCloud "is a therapeutic software tool for the treatment of chronic subjective tinnitus for home use" and is "intended to provide relief from the disturbance of chronic subjective tinnitus."
No
The "Intended Use" section clearly states that the device is a "therapeutic software tool for the treatment of chronic subjective tinnitus," designed to provide "relief from the disturbance of chronic subjective tinnitus." It does not mention any diagnostic capabilities.
Yes
The device is described as a "therapeutic software tool" and there is no mention of any associated hardware components in the provided text.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of chronic subjective tinnitus. IVDs are used for the diagnosis or monitoring of diseases or conditions by examining specimens taken from the human body (like blood, urine, tissue).
- Device Description: While the description is "Not Found," the intended use clearly points to a therapeutic function, not a diagnostic one.
- Input Imaging Modality: "Not Applicable" further supports that it's not an imaging-based diagnostic device.
- Anatomical Site: "Not Found" is consistent with a software tool that doesn't directly interact with a specific anatomical site for diagnostic purposes.
The SilentCloud is described as a "therapeutic software tool" used in combination with a "Tinnitus Management Program" for home use. This aligns with a device designed to provide relief or manage a condition, which is characteristic of a therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
The SilentCloud in combination with a Tinnitus Management Program is a therapeutic software tool for the treatment of chronic subjective tinnitus for home use.
The target population for the Universal Tinnitus Management System are adult tinnitus patients over 18 years. The SilentCloud is intended to provide relief from the disturbance of chronic subjective timitus while using the device.
The SlientCloud is fitted and programmed by a qualified healthcare professional familiar with timitus treatment.
Product codes
KLW
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult tinnitus patients over 18 years.
Intended User / Care Setting
qualified healthcare professional familiar with timitus treatment.
for home use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.3400 Tinnitus masker.
(a)
Identification. A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises. Because the device is able to mask internal noises, it is also used as an aid in hearing external noises and speech.(b)
Classification. Class II. The special control for this device is patient labeling regarding:(1) Hearing health care professional diagnosis, fitting of the device, and followup care,
(2) Risks,
(3) Benefits,
(4) Warnings for safe use, and
(5) Specifications.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
January 4, 2023
Aureliym GmBH Markus Haller CEO Hauptstrasse 96 Bad Neuenahr-Ahrweiler, D-53474 Germany
Re: K221125
Trade/Device Name: SilentCloud Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: December 6, 2022 Received: December 6, 2022
Dear Markus Haller:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shuchen Peng -ഗ Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory. ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221125
Device Name SilentCloud
Indications for Use (Describe)
The SilentCloud in combination with a Tinnitus Management Program is a therapeutic software tool for the treatment of chronic subjective tinnitus for home use.
The target population for the Universal Tinnitus Management System are adult tinnitus patients over 18 years. The SilentCloud is intended to provide relief from the disturbance of chronic subjective timitus while using the device.
The SlientCloud is fitted and programmed by a qualified healthcare professional familiar with timitus treatment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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